Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Adult	NCI	MSKCC-00054 NCI-G01-1918, NCT00012090

Objectives

I. Determine the time-to-treatment failure in patients with ovarian 
epithelial, fallopian tube, or peritoneal carcinoma, in second or greater 
remission, treated with bicalutamide and goserelin.

II. Assess luteinizing hormone and follicle-stimulating hormone suppression in 
correlation with serum vascular endothelial growth factor levels, and 
determine if these levels are related to time to treatment failure in these 
patients.

III. Correlate the presence or absence of androgen receptor tissue expression 
by immunohistochemistry and androgen receptor gene trinucleotide repeat length 
to time to treatment failure in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed epithelial carcinoma arising in the ovary, fallopian
tube, or peritoneum, in second or greater remission

Failed initial therapy with persistent or recurrent disease
 Cytoreductive surgery AND
 At least 1 platinum-based chemotherapy regimen

No evidence of disease within 4 months of salvage chemotherapy
 CA-125 less than 35 U
 Negative physical exam
 No abdominal or pelvic disease by CT

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 See Disease Characteristics

Other:
 No concurrent oral anticoagulants

Patient Characteristics:

Age:
 Adult

Performance status:
 Karnofsky 60-100%

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 1,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin less than 2 times upper limit of normal (ULN)
 SGOT less than 2 times ULN
 Alkaline phosphatase less than 2 times ULN

Renal:
 Not specified

Other:
 No other active invasive malignancy
 No inability to receive subcutaneous injection
 No inability to tolerate oral medication

Expected Enrollment

A total of 35 patients will be accrued for this study.

Outline

Patients receive oral bicalutamide once daily and goserelin subcutaneously 
once every 4 weeks.  Treatment continues in the absence of unacceptable 
toxicity until disease recurrence.

Levine D, Park K, Juretzka M, et al.: A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission. Cancer 110 (11): 2448-56, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Paul Sabbatini, MD, Protocol chair		Ph: 212-639-6423; 800-525-2225

Registry Information
Official Title		A Phase II Trial Of Oral Bicalutamide With Subcutaneous Goserelin In Patients With Epithelial Ovarian, Fallopian Tube, Or Peritoneal Carcinoma In Second Or Greater Remission
Trial Start Date		2000-09-21
Registered in ClinicalTrials.gov		NCT00012090
Date Submitted to PDQ		2001-01-10
Information Last Verified		2007-11-27
NCI Grant/Contract Number		CA08748

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